Support for all requests for CE marking and compliance with the requirements of ISO standards


Quality support

The experience acquired by our teams over more than 30 years enables us to assist our customers in the process of obtaining the CE marking - or FDA 510k approval - of their products. We also assist them in monitoring changes and requirements of ISO standards applied to their products.

Our strengths

  • QMS designed to comply with normative and regulatory requirements applicable to the medical field: ISO 13485, 21 CFR part 820, MDD 93/42/EEC, etc.
  • Anticipation of new European MDR regulations and ability to certify our products according to new requirement
  • Proven experience, skilled and motivated team

New European MDR regulations

In anticipation of the implementation of the new European regulation on medical devices, we have assessed our shortcomings and anticipated the steps to be taken. In December 2018, we obtained a new MDD certification for Class IIa devices. In February 2020, all our Class Ir products will be certified according to the MDR requirements. In the longer term, and no later than December 2023, we will obtain MDR certifications for the Class IIa devices.



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